The RAP technology is designed to harness the power of sound for the treatment of cellulite.
Soliton Inc announced that the U.S. Food and Drug Administration (FDA) has cleared its Rapid Acoustic Pulse (RAP) technology for the short-term improvement in the appearance of cellulite. The technology is designed to harness the power of sound for the treatment of cellulite. According to the company, the rapid-pulsed technology safely and comfortably breaks apart the fibrous septa bands beneath the skin that cause cellulite to deliver efficacious results in one, 40 to 60-minute treatment.
“We’re thrilled to receive this latest clearance for our RAP technology,” said Brad Hauser, president and chief executive officer of Soliton. “Our technology will now provide physicians a new, innovative and non-invasive approach for patients seeking a non-surgical option to improve the appearance of cellulite. This latest clearance also marks the next step in the planned commercialization of our RAP technology, and we look forward to introducing this new approach to treating cellulite to physicians in the months to come.”
In the clinical trials submitted to the FDA as part of the 510(k) application that was cleared, patient results were generated by a single, non-invasive treatment that required no anesthesia, caused no unexpected or serious adverse events, received strong patient satisfaction ratings and was well tolerated by the trial subjects, with an average pain score of 2.4 out of 10. The RAP device is designed to induce mechanical disruption in fibrous structures, such as the septae contributing to dimples in cellulite, that results in release of the dimples and general smoothing of the skin.
